Lab Clinico Y De Referencia Del Este

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on April 7, 2025 to Laboratorio Clinico Referencia Del Este, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Ova/& Parasite (presence or absent) tests. Refer D2055. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2055 PARASITOLOGY CFR(s): 493.829(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for Ova & Parasite tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Ova & Parasite (presence or absent) a. First testing event year 2024 - 60% b. Third testing event year 2024 - 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of Puerto Rico proficiency testing scores (year 2024) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Ova & Parasite (presence or absent) tests. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on Puerto Rico proficiency testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Ova & Parasite (presence or absence) tests during the first testing event of the year 2024 and third testing event of the year 2024. Refer to D2055. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on COVID 19 test report, Puerto Rico Department of Health (PRDOH) COVID 19 state reporting requirement and laboratory general supervisor interview on August 17, 2021 at 12:10 PM, it was determined that the laboratory did not follow the state COVID 19 test reporting requirements. The findings include: 1. The PRDOH requires that all COVID 19 tests report must be informed within 24 hours of the final report, to the Bio Portal platform. 2. The laboratory used the Healgen rapid test for antibody (IgG / IgM) test kit, SARS COV19 Antigen FIA (SOFIA) for antigen test kit and Id Now (Abbott) for molecular COVID 19 test. 3. The test report records showed that 2 out of 4 days from April 22, 2021 to April 25, 2021 and 3 out of 6 days from May 14, 2021 to May 21, 2021. The laboratory did not report the SARS-CoV-IgG / IgM (Healgen), antigen (FIA) and molecular (ID NOW) patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date test tested specimens reported 04/23/2021 22 04/26/2021 IgG/IgM 04/23/2021 87 04/26/2021 Antigen FIA 04/23 /2021 31 04/26/2021 Molecular (ID NOW) 04/24/2021 10 04/26/2021 IgG/IgM 05/17 /2021 10 05/19/2021 IgG/IgM 05/17/2021 01 05/25/2021 IgG/IgM 05/17/2021 44 05 /19/2021 Antigen FIA 05/19/2021 07 05/25/2021 IgG/IgM 05/19/2021 37 05/25/2021 Antigen FIA 05/19/2021 32 05/25/2021 Molecular (ID NOW) 05/202021 12 05/25 /2021 IgG/IgM 05/20/2021 59 05/25/2021 Antigen FIA 05/20/2021 20 0525/2021 Molecular (ID NOW) Total of report greater than 24 hours: 352 reports. 4. The laboratory general supervisor confirmed on August 17, 2021 at 12:10 PM, that the before mentioned tests were not reported within the 24 hours of the final test report. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on COVID 19 test report, Puerto Rico Department of Health (PRDOH) COVID 19 state reporting requirement and laboratory general supervisor interview on August 17, 2021 at 12:10 PM, it was determined that the laboratory did not follow the state COVID 19 test reporting requirements. The findings include: 1. The PRDOH requires that all COVID 19 tests report must be informed within 24 hours of the final report, to the Bio Portal platform. 2. The laboratory used the Healgen rapid test for antibody (IgG / IgM) test kit, SARS COV19 Antigen FIA (SOFIA) for antigen test kit and Id Now (Abbott) for molecular COVID 19 test. 3. The test report records showed that 2 out of 4 days from April 22, 2021 to April 25, 2021 and 3 out of 6 days from May 14, 2021 to May 21, 2021. The laboratory did not report the SARS-CoV-IgG / IgM (Healgen), antigen (FIA) and molecular (ID NOW) patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date test tested specimens reported 04/23/2021 22 04/26/2021 IgG/IgM 04/23/2021 87 04/26/2021 Antigen FIA 04/23 /2021 31 04/26/2021 Molecular (ID NOW) 04/24/2021 10 04/26/2021 IgG/IgM 05/17 /2021 10 05/19/2021 IgG/IgM 05/17/2021 01 05/25/2021 IgG/IgM 05/17/2021 44 05 /19/2021 Antigen FIA 05/19/2021 07 05/25/2021 IgG/IgM 05/19/2021 37 05/25/2021 Antigen FIA 05/19/2021 32 05/25/2021 Molecular (ID NOW) 05/202021 12 05/25 /2021 IgG/IgM 05/20/2021 59 05/25/2021 Antigen FIA 05/20/2021 20 0525/2021 Molecular (ID NOW) Total of report greater than 24 hours: 352 reports. 4. The laboratory general supervisor confirmed on August 17, 2021 at 12:10 PM, that the before mentioned tests were not reported within the 24 hours of the final test report. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Immuno Concepts ANA HEp-2000 manufacturer's instruction, antinuclear antibody (ANA) quality control records (years 2018 and 2019) and interview with testing personnel ( MT-1 and MT-2) on June 18, 2019 at 12:30 PM, it was determined that the laboratory failed to meet the requirements of the General Immunology (Ana tests). Refer to D 5405- The laboratory failed to follow manufacturer's instruction when performed ANA test on December 14, 2018, December 27, 2018, December 28, 2018 and June 7, 2019. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on antinuclear antibody test ( ANA) manufacturer's instruction review, antinuclear antibody test quality control records review ( year 2018-2019) and laboratory testing personnel interview ( MT-1 and MT-2) on June 18, 2019 at 10:30 A. M., it was determined that the laboratory failed to follow manufacturer's instruction Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- when performed the ANA test . The findings include: 1. The laboratory performed ANA test by Hep-2000 Colorzyme ANA-Ro test system . 2. The manufacturer's instruction establishes that a positive, negative and Phosphate buffered saline powder ( PBS ) controls should be run in the wells provided for quality control on each slide. The kit provided a substrate slides with ten wells. 3. The antinuclear antibody quality control records showed that the following days the laboratory performed ANA test patient samples and did not include controls materials on each slide: December 14, 2018- 28 patient samples December 27, 2018 -17 patient samples December 28, 2018- 6 patient samples June 7, 2019- 30 patient samples 4. All patient result were reviewed and found that these results were negative for antinuclear antibody. 5. The laboratory testing personnel ( MT-1 and MT-2) confirmed on June 18, 2019 at 12:00 P.M, that the laboratory included a positive, negative and PBS controls ) with each day of testing instead with each slide. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on quality assessment (QA) records review( year 2018-2019) and testing personnel ( MT-1 ) on June 18, 2019 at 9:30 A.M, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The finding includes: 1. The laboratory did not evaluate aspects regarding: failed to follow manufacturer's instruction when performed the ANA test . Refer to D5405. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on General Immunology quality control records review ( year 2018-2019) and interview with the laboratory testing personnel ( MT-1) on June 18, 2019 at 11:30 A. M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system requirements for General Immunology. The finding includes: 1. The laboratory director failed to ensure compliance with the General Immunology requirements. Refer to D6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on General Immunology quality control records review ( year 2018-2019) and laboratory testing personnel ( MT-1) interview on June 18, 2019 at 12:30 P.M, it was determined that laboratory failed to ensure compliance with the requirements for analytic systems. Refer to D5405. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on General Immunology quality control records review ( year 2018-2019) and testing personnel ( MT-1) interview on June 18, 2019 at 12:00 P.M., it was determined that the general supervisor failed to perform day-to-day supervision for the personnel that performing testing and reporting test results. Refer to D 5405. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on antinuclear antibody test ( ANA) manufacturer's instruction review, antinuclear antibody test quality control records review ( year 2018-2019) and laboratory testing personnel interview ( MT-1 and MT-2) on June 18, 2019 at 10:30 A. M., it was determined that the laboratory testing personnel failed to follow manufacturer's instruction when performed the ANA test . Refer to D5405. -- 3 of 3 --